Overview

Effects Of Pregabalin (Lyrica) On Sleep Maintenance In Subjects With Fibromyalgia

Status:
Completed
Trial end date:
2010-06-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of the study is to demonstrate the effect of Lyrica on Wake after sleep onset in subjects with fibromyalgia with sleep maintenance disturbance (on polysomnogram)
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Pfizer
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Treatments:
Pregabalin
Criteria
Inclusion Criteria:

- Subjects must meet diagnostic criteria for fibromyalgia;

- Subjects must report difficulty in maintaining sleep at least 3 times per week and
meet Research Diagnostic Criteria (RDC) for insomnia disorder, corroborated by subject
diary, and meet PSG inclusion criteria at visit 3.

Exclusion Criteria:

- History of active sleep disorder other than Research Diagnostic Criteria(RDC) insomnia
criteria or any sleep or circadian rhythm disturbance;

- Use of medications known to affect sleep wake function by Visit 2;

- Involved in night or rotating shift work, or travel across >4 time zones 14 days prior
to screening and during study; regular daytime napping

- PSG finding of apnea/hypopnea or periodic limb movement with arousal index >10/hr on
either night of PSG.